Yackobovitch-Gavan Michal, Lebenthal Yael, Lazar Liora, Shalitin Shlomit, Demol Sharon, Tenenbaum Ariel, Shamir Raanan, Phillip Moshe
The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.
The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
J Pediatr. 2016 Dec;179:154-159.e1. doi: 10.1016/j.jpeds.2016.08.100. Epub 2016 Sep 30.
To determine the 1-year effectiveness and safety of nutritional supplementation with the study formula on linear growth and weight gain in short and lean prepubertal children and to validate the previously reported findings in those initially treated with placebo.
Two-phase 1-year intervention (double-blind placebo-controlled [0-6 months] and open-labeled extension [6-12 months]) in which all participants were offered to continue the study using the study formula. Anthropometric measures and 3-day food diary were assessed at baseline and after 6 and 12 months of intervention.
A total of 129 out of 150 children (86%) completed the open-labeled extension-phase. In "good" consumers of the formula (intake ≥50% of recommended dose) throughout the entire year height-SDS continued to improve in the extension phase, with a total gain of 0.19 ± 0.14 SD. In "good" consumers of the formula initially randomized to the placebo-group, the gain in height-SDS significantly improved (from 0.04 ± 0.13 to 0.12 ± 0.11; P = .001), replicating the results of the "good" consumers of the formula during the blinded-phase (0.12 ± 0.12). "Poor" consumers (intake <50% of recommended dose) did not improve their height-SDS. No significant changes in body mass index SDS were observed with the consumption of the formula. A dose-response was found between the amount of formula consumed/kg and the increment in height-SDS and weight-SDS (r = 0.36; P < .001 and r = 0.18; P = .041, respectively). No serious adverse events were reported.
One year of a nutritional supplement was effective in promoting the linear growth of short and lean prepubertal children, with no change in body mass index status.
ClinicalTrials.gov:NCT01158352.
确定使用研究配方进行营养补充对矮小且消瘦的青春期前儿童线性生长和体重增加的1年有效性及安全性，并验证先前在最初接受安慰剂治疗的儿童中所报告的结果。
为期1年的两阶段干预（双盲安慰剂对照[0 - 6个月]和开放标签扩展[6 - 12个月]），所有参与者都被提供使用研究配方继续该研究。在基线以及干预6个月和12个月后评估人体测量指标和3天食物日记。
150名儿童中有129名（86%）完成了开放标签扩展阶段。在全年“良好”摄入配方的儿童（摄入量≥推荐剂量的50%）中，扩展阶段身高标准差得分（height-SDS）持续改善，总增益为0.19±0.14标准差。在最初随机分配到安慰剂组的配方“良好”摄入儿童中，身高标准差得分显著改善（从0.04±0.13提高到0.12±0.11；P = 0.001），重复了双盲阶段配方“良好”摄入儿童的结果（0.
